AstraZeneca ($AZN) unveiled its pricing plan for the new targeted lung cancer pill Tagrisso that won early FDA approval Friday: $12,750 per month, or $153,000 for a full year of treatment. That's on par with other targeted cancer pills, including the company's own Iressa, a spokeswoman tells Reuters.
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| AstraZeneca CEO Pascal Soriot |
And with a potential rival from Clovis Oncology ($CLVS) questioned by the FDA--and its efficacy data knocked down, to boot--AstraZeneca has a better chance of getting Tagrisso to pay off.
The company has predicted $3 billion in peak sales for Tagrisso, making it a key element of its strategy for growing sales. That's a big target, even in a field as hot as oncology. But Tagrisso, which targets tumors with an EGFR gene mutation, has some solid efficacy data to back it up. In a statement about the approval, Dr. Richard Pazdur, who heads up the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, noted "substantial evidence from clinical trials that shows Tagrisso had a significant effect on reducing tumor size in over half of patients who were treated."
In fact, Tagrisso's efficacy data looks even better now that Clovis' rociletinib (CO-1686) data has come up for questioning at the FDA. As FierceBiotech reported Monday, the FDA asked Clovis to submit fresh data for the drug--and that new data includes a response rate that's significantly worse than expected. The now-confirmed response rate was 20% lower than the unconfirmed rate originally reported to the FDA, Clovis CEO Patrick Mahaffey told analysts as his company's shares were sliding on the news.
Clovis had been eyeing an approval for its drug by mid-March, but the new data submission could delay that--giving AstraZeneca more time to capitalize on its first-to-market advantage.
AstraZeneca will need every advantage it can get to push Tagrisso to that $3 billion sales figure--and its overall sales to the $45 billion CEO Pascal Soriot promised when fending off a takeover attempt by Pfizer ($PFE) last year.
- get the Reuters story
- see the FDA's release
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